Impact of Sleep Quality on Respiratory Function and Weani... | NCT02920281

Studies
Impact of Sleep Quality on Respiratory Function and Weaning of Mechanical Ventilation

NCT02920281

Sponsor

Poitiers University Hospital

Status

Completed

Last Update Posted

Jan 17, 2018Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Sleep Quality
Weaning of Mechanical Ventilation

Interventions

Polysomnography

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Apr 2017Actual

Completion Date

Apr 2017Actual

First Submitted Date

Sep 29, 2016

First Submission Date that Met QC Criteria

Sep 29, 2016

First Posted Date

Sep 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2018

Last Update Posted Date

Jan 17, 2018Actual

Description Module

Brief Summary

The aim of the study is to evaluate the impact of sleep quality on the length of mechanical ventilation weaning, in intensive care unit patients

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
Polysomnography	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compare the length of weaning patients who have a poor quality of sleep to those who have a good quality sleep.		24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mechanical ventilation for at least 24 hours before the first weaning test
difficult weaning of mechanical ventilation defined as failure to the first weaning test
patients aged at least of 18 years

Exclusion Criteria:

peripheral or central nervous system pathology
known psychiatric pathology or agitation
clinical worsening before polysomnography (shock with vasopressor drugs, coma with Glasgow scale < 8, PaO2/FiO2 ratio < 150 with respiratory distress signs)
pregnant or breastfeeding women
patient under legal guardianship or protection
patient with no health insurance coverage
age < 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Poitiers		Poitiers		86000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29519925	Derived	Thille AW, Reynaud F, Marie D, Barrau S, Rousseau L, Rault C, Diaz V, Meurice JC, Coudroy R, Frat JP, Robert R, Drouot X. Impact of sleep alterations on weaning duration in mechanically ventilated patients: a prospective study. Eur Respir J. 2018 Apr 19;51(4):1702465. doi: 10.1183/13993003.02465-2017. Print 2018 Apr.

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases